SAN DIEGO, CA--(Marketwired - Aug 27, 2015) - Aegis Therapeutics LLC announced today that it has been awarded US Patent No. 9,114,069 titled "Antibacterial Compositions for Drug Administration" providing non-toxic formulations of parathyroid hormone and related analogs, including teriparatide (PTH 1-34), suitable for injectable or metered nasal spray administration having intrinsic antimicrobial activity. The patent formulations meet the FDA's antimicrobial effectiveness test criteria set forth in USP < 51 > without the need for metacresol, an antimicrobial agent currently used in commercial formulations of teriparatide as well as certain insulins. Metacresol is irritating and/or a sensitizer to skin, eyes and mucous membranes and is classified as a possible carcinogen.
Human clinical studies have shown that formulations of teriparatide based upon Aegis' Intravail®/ProTek® technology show excellent nasal bioavailability offering the prospect of a "first in class" non-injectable PTH drug for treatment of osteoporosis. Non-injectable dosage forms of previously injectable-only drugs provide greater patient convenience and acceptance, improved compliance, and avoidance of needle-stick injury and disposal problems associated with the use of needles.
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